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The objective of the study is to evaluate the safety and efficacy of DMT210 Gel, 5% compared to vehicle control following 28 days of twice-daily topical application to selected target lesions in male and female patients with mild to moderate atopic dermatitis (AD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DMT210 Topical Gel | Experimental | DMT210 Topical Gel 5% applied to target lesion twice daily |
|
| Vehicle Control | Placebo Comparator | Topical Gel vehicle applied to target lesion twice daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DMT210 Topical Gel | Drug | DMT210 Topical Aqueous Gel 5% applied twice daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| ADSI (Atopic Dermatitis Severity Index) score of each Target lesion | Change from baseline in ADSI score between Vehicle and 5% gel | Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Individual Signs and Symptoms of Atopic Dermatitis of each Target Lesion | Change from baseline in AD symptom scores between Vehicle and 5% gel | Day 28 |
| Investigator Global Assessment (IGA) of the Treatment Area |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events as a measure of safety and tolerability | Day 28 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher Nardo, PhD | Dermata Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dermata Investigational Site | Houston | Texas | 77056 | United States | ||
| Dermata Investigational Site |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| D004485 | Eczema |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D012873 | Skin Diseases, Genetic |
| D017443 | Skin Diseases, Eczematous |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| ID | Term |
|---|---|
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D017437 | Skin and Connective Tissue Diseases |
| D006969 | Hypersensitivity, Immediate |
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| Vehicle Control |
| Drug |
Topical Vehicle Gel applied twice daily |
|
| Day 28 |
| Norfolk |
| Virginia |
| 23502 |
| United States |